Surgical apparatus and structure for applying sprayable wound treatment material

ABSTRACT

According to an aspect of the present disclosure, an apparatus for forming an anastomosis between adjacent sections of tissue is provided. The apparatus includes a body portion; an actuation assembly operatively supported at a proximal end of the body portion; an anvil assembly movably mounted at the distal end of the body portion for movement toward and away from the body portion; an approximation assembly extending between the body portion and the anvil assembly for moving the anvil toward and away from the tubular body portion; a dispersion assembly operatively associated with the approximation assembly, the dispersion assembly including at least one angled surface defining at least one channel interposed between the anvil assembly and the body portion and being configured to dispense a fluid therefrom; and at least one conduit for conducting wound treatment material to the dispersion assembly.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present disclosure claims the benefit of and priority to U.S.Provisional Application 60/620,168, filed Oct. 18, 2004, U.S.Provisional Application 60/620,151, filed Oct. 18, 2004, U.S.Provisional Application 60/620,171, filed Oct. 18, 2004, and U.S.Provisional Application 60/620,150, filed on Oct. 18, 2004, the entirecontents of each of which being incorporated herein by reference.

BACKGROUND

1. Technical Field

The present disclosure relates to surgical apparatus and methods forenhancing properties of tissue repaired or joined by surgical staplesand, more particularly to surgical apparatus and structure configured toapply surgical mechanical fasteners and/or a non-mechanicalbiocompatible wound treatment material to enhance the properties ofrepaired or adjoined tissue at a target surgical site.

2. Discussion of Related Art

Throughout the years the medical field has utilized various techniquesin an effort to join or bond body tissue together. Historically,suturing was the accepted technique for rejoining severed tissues andclosing wounds. Suturing was historically achieved with a surgicalneedle and a suturing thread, and more recently, with a variety ofpolymeric or metallic staples, as will be discussed below. The intendedfunction of sutures is to hold the edges of a wound or tissue againstone another during the healing process so as to reduce discomfort, pain,scarring and the time required for healing.

Recently, many procedures which in the past required conventionalsuturing have been replaced by staple suturing which involves theapplication of the staples to the edges of the wound or tissue with theuse of a surgical stapler. Surgical staplers have been developed forjoining adjacent tissue, for providing hemostasis of adjacent tissue andfor providing hemostasis in conjunction with cutting of adjacent tissue.Such surgical staplers include both linear and annular typeconfigurations. A typical linear stapler and cutter includes parallelrows of staples with a slot for a cutting means to travel between therows of staples.

Typical linear type staplers are disclosed in commonly assigned U.S.Pat. No. 6,045,560 to McKean et al., U.S. Pat. No. 6,032,849 to Mastriet al., and U.S. Pat. No. 5,964,394 to Robertson, the entire contents ofeach of which are incorporated herein by reference. A typical annularstapler and cutter, including a plurality of annular rows of staples,typically two, and an annular blade disposed internal of the rows ofstaples, is disclosed in commonly assigned U.S. Pat. No. 5,799,857 toRobertson et al. and U.S. Pat. No. 5,915,616 to Viola et al., the entirecontents of each of which are incorporated herein by reference.

These types of surgical staplers secure adjoining body tissue forimproved cutting, join layers of tissue to one another and providehemostasis by applying parallel or annular rows of staples tosurrounding tissue as the cutting means cuts between the parallel orannular rows. Accordingly, by enabling a surgeon to perform all of thesetasks simultaneously, surgical staplers have been effective indecreasing the amount of time it takes to fasten tissue together. Toeven further enhance joining and hemostasis in instances where thestapler is used in highly vascularized tissue, surgical staplers withmultiple rows of staples have been used with a high degree of success.

Other surgical procedures utilize pledgets, buttresses or other types ofreinforcement materials and fabrics. These buttresses are typicallyplaced over the tissue contacting surface of the anvil and/or the tissuecontacting surface of the cartridge of the surgical stapling instrumentand secured against the target tissue during the firing of the surgicalstapling instrument. Reference may be made to U.S. Pat. No. 5,542,594,the entire content of which is incorporated herein by reference, for amore detailed discussion of the use of buttresses in cooperation withsurgical stapling instrument.

Still other surgical procedures involve the step of applying (e.g., byspraying, brushing, etc.) an adhesive material and/or a sealant materialto the external surface of the target surgical site following thesurgical stapling procedure.

Another procedure which has been developed includes the use ofbiological tissue adhesives have recently been developed for tissuerepair and the creation of anastomoses. Generally, biological adhesivesbond separated tissues together to aid in the healing process and toenhance the tissue strength. Such adhesives may be used instead ofsuturing and stapling for example in surgical procedures for the repairof tissue or the creation of anastomoses.

The application of a suitable biocompatible adhesive offers manyadvantages to the patient and the surgeon alike such as, for example,the avoidance of penetration of tissue by needles and/or staples, aswell as the immediate sealing of the tissue being treated. Moreover, useof a biocompatible adhesive tends to minimize foreign body reaction andscarring. Despite these advantages, however, the weakness along thetissue seam remains as a primary disadvantage in the use ofbiocompatible adhesives.

Therefore, there is a need for surgical stapler instruments, for examplesurgical fasteners or staplers which reduce the trauma suffered by apatient, reduce the number of gaps between or at individual staplesites, reduce leakage of fluids, reduce bleeding, and/or which create arelatively strong bond between adjacent body tissues, e.g., along staplelines and tissue seams.

SUMMARY

The present disclosure relates to surgical instrument, structures,apparatus and methods for enhancing the properties of tissue to berepaired or joined.

According to an aspect of the present disclosure, an apparatus forforming an anastomosis between adjacent sections of tissue is provided.The apparatus includes a body portion; an actuation assembly operativelysupported at a proximal end of the body portion; an anvil assemblymovably mounted at the distal end of the body portion for movementtoward and away from the body portion; an approximation assemblyextending between the body portion and the anvil assembly for moving theanvil toward and away from the tubular body portion; a dispersionassembly operatively associated with the approximation assembly, thedispersion assembly including at least one angled surface defining atleast one channel interposed between the anvil assembly and the bodyportion and being configured to dispense a fluid therefrom; and at leastone conduit for conducting wound treatment material to the dispersionassembly.

The dispersion assembly may include a manifold. The manifold includes aplurality of ejection ports for dispensing the wound treatment material,wherein the channel directs the fluid across the ejection ports.

The ejection ports may include a plurality of first ejection portsformed therein for dispensing a first wound treatment material; and aplurality of second ejection ports formed therein for dispensing asecond wound treatment material different from the first wound treatmentmaterial. The plurality of first ejection ports and the plurality ofsecond ejection ports are both provided on opposed sides of themanifold. The plurality of proximal ejection ports and the plurality ofdistal ejection ports may be radially oriented.

The at least one conduit may include a first conduit having a distal endin fluid communication with the plurality of first ejection ports formedin the manifold; and a second conduit having a distal end in fluidcommunication with the plurality of second ejection ports formed in themanifold. It is envisioned that a distal end portion of the manifold maybe tapered at an angle relative to a longitudinal axis of the bodyportion. It is further envisioned that the plurality of first ejectionports and the plurality of second ejection ports may be disposed in adistal end portion of the manifold.

The dispersion assembly may further include a cap operatively connectedto a distal end of the manifold in such a manner so as to define achannel between an outer surface of the distal end portion of themanifold and an inner surface of the cap. The at least one ejection portmay includes at least one third ejection port that communicates with thechannel defined between the outer surface of the distal end portion ofthe manifold and the inner surface of the cap. The apparatus may furtherinclude a third conduit having a distal end in fluid communication withthe third ejection port.

The first conduit may be connectable to a first fluid source, the secondconduit may be connectable to a second fluid source, and the thirdconduit may be connectable to a third fluid source. The first fluidsource may include a first part of a multi-part wound treatmentmaterial, and the second fluid source may include a second part of themulti-part wound treatment material. The multi-part wound treatmentmaterial is a sealant. The third source may include a fluid.

The cap and the distal end portion of the manifold may be shaped so thatthe channel directs the fluid in a substantially proximal direction.Accordingly, the fluid ejected from the channel causes the first andsecond parts of the multi-part wound treatment material to mix.

The actuation assembly may include at least one handle connected to thebody portion. The approximation assembly may include a threaded rodmember threadingly engaging the at least one handle; and a knob memberoperatively connected to a proximal end of the threaded rod member. Thedispersion assembly may be operatively associated with the distal end ofthe threaded rod member. The threaded rod member may include windowsformed on opposite sides thereof. The windows may be in registrationwith the at least one ejection port.

The distal end of the threaded rod member may include a connectionmember defining the windows. A distal end of the connection member maybe configured to selectively engage a stem of an anvil assembly.

Accordingly to a further aspect of the present disclosure, a method ofperforming a surgical anastomosis procedure is provided. The methodincludes the steps of providing a surgical anastomosis apparatus havingan anvil assembly movably mounted with respect to a body portion and awound treatment material dispersion system disposed between the anvilassembly and the body portion for dispensing wound treatment materialonto a target surgical site. The wound treatment material dispersionapparatus includes at least one ejection port configured to dispense atleast one fluid; and at least one conduit for conducting wound treatmentmaterial to the wound treatment material dispersion apparatus.

The method further includes the steps of disposing an anvil assemblyinto a first intestinal section and securing the first intestinalsection to the anvil assembly; disposing the body portion into a secondintestinal section and securing the second intestinal section to thebody portion; actuating the wound treatment material dispersionapparatus to dispense wound treatment material onto at least one of thefirst and the second intestinal sections; and approximating the anvilassembly toward the tubular body portion.

The method further includes the steps of dispensing a first part of amulti-part wound treatment material from a first set of ejection portsformed in the wound treatment material dispersion apparatus; anddispensing a second part of the multi-part wound treatment material froma second set of ejection ports formed in the wound treatment materialdispersion apparatus.

The method further includes the step of mixing the first and second partof the multi-part wound treatment material. It is envisioned that thefirst and second parts of the multi-part wound treatment material aredispensed in a radially outward direction.

The method may further include the step of dispensing a fluid from thewound treatment material dispersion apparatus, in a direction transverseto the paths of dispersion of the first and second parts of the woundtreatment material. It is contemplated that the fluid may be dispensedfrom the wound treatment material dispersion apparatus in asubstantially proximal direction.

The method may further include the steps of ejecting a first fluid froma proximal set of ejection ports; and ejecting a second fluid from adistal set of ejection ports.

The method may still further include the steps of delivering the firstfluid through a first conduit to the first set of ejection ports, from afirst source of the first fluid; and delivering the second fluid througha second conduit to the second set of ejection ports from a secondsource of a second fluid.

It is envisioned that the multi-part wound treatment material may beselected from the group consisting of a two-part bio-adhesive and atwo-part sealant.

The approximation assembly may include an inner rod member defining alumen therethrough; a threaded rod member operatively associated with aproximal end of the inner rod member, wherein the treaded rod memberthreadingly engages the fixed handle member; a knob member operativelyconnected to a proximal end of the threaded rod member; and a connectionmember operatively connected proximate to a distal end of the inner rodmember.

The wound treatment material dispersion apparatus may be operativelyassociated with the distal end of the inner rod member. The connectionmember may include windows formed on opposite sides thereof. The windowsof the connection member may be in registration with the plurality ofproximal ejection ports and the plurality of distal ejection ports ofthe manifold.

According to an aspect of the present disclosure, a circular surgicalstapling apparatus is provided. The surgical stapling apparatus includesa tubular body portion having an actuator; a staple pusher memberoperatively disposed at a distal end of the tubular body portion andbeing operatively connected to the actuator for expelling an annulararray of staples from the tubular body portion; an anvil assemblymovably mounted at the distal end of the tubular body portion formovement toward and away from the tubular body portion; an approximationassembly extending between the tubular body portion and the anvilassembly for moving the anvil toward and away from the tubular bodyportion; a nozzle operatively associated with the approximationassembly, the nozzle including at least one ejection port disposedbetween the anvil assembly and the tubular body portion and beingconfigured to dispense at least one fluid; and at least one conduit forconducting wound treatment material to the nozzle.

The nozzle may include a manifold. The manifold includes a plurality offirst ejection ports formed therein for dispensing a first woundtreatment material; and a plurality of second ejection ports formedtherein for dispensing a second wound treatment material different fromthe first wound treatment material. The plurality of first ejectionports and the plurality of second ejection ports may both be provided onopposed sides of the manifold. The plurality of proximal ejection portsand the plurality of distal ejection ports may be radially oriented.

The at least one conduit may include a first conduit having a distal endin fluid communication with the plurality of first ejection ports formedin the manifold; and a second conduit having a distal end in fluidcommunication with the plurality of second ejection ports formed in themanifold. A distal end portion of the manifold may be tapered at anangle relative to a longitudinal axis, and the plurality of firstejection ports and the plurality of second ejection ports may bedisposed in the distal end portion of the manifold.

The nozzle further includes a cap operatively connected to a distal endof the manifold in such a manner so as to define a channel between anouter surface of the distal end portion of the manifold and an innersurface of the cap. The at least one ejection port may include at leastone third ejection port that communicates with the channel.

The apparatus may further include a third conduit having a distal end influid communication with the third ejection port. Accordingly, the firstconduit may be connectable to a first fluid source, the second conduitmay be connectable to a second fluid source, and the third conduit maybe connectable to a third fluid source. The first fluid source mayinclude a first part of a two-part wound treatment material, and thesecond source may include a second part of the two-part wound treatmentmaterial. The two-part wound treatment material may be a bio-adhesive.The third fluid source may include a compressed fluid.

The cap and the distal end portion of the manifold may be shaped so thatthe channel directs the fluid into a substantially proximal direction.In use, the fluid ejected from the channel causes the first and secondparts of the two-part wound treatment material to mix.

The actuator includes at least one handle connected to the tubular bodyportion. The approximation assembly includes a threaded rod memberthreadingly engaging the at least one handle; and a knob memberoperatively connected to a proximal end of the threaded rod member. Thenozzle of the wound treatment material dispersion system may beoperatively associated with the distal end of the threaded rod member.The threaded rod member may include windows formed on opposite sidesthereof. The windows may be in registration with the at least oneejection port. The distal end of the threaded rod member may include aconnection member defining the windows, and a distal end of theconnection member may be configured to selectively engage a stem of ananvil assembly.

According to another aspect of the present disclosure, a method ofperforming a surgical anastomosis procedure is provided. The methodincludes the steps of providing a circular surgical stapling apparatushaving an anvil assembly movably mounted with respect to a tubular bodyportion and a wound treatment material dispersion system for dispensingwound treatment material onto a target surgical site. The woundtreatment material dispersion system includes a nozzle disposed betweenthe anvil assembly and the tubular body portion, the nozzle including atleast one ejection port configured to dispense at least one fluid; andat least one conduit for conducting wound treatment material to thenozzle.

The method further includes the steps of disposing an anvil assemblyinto a first intestinal section; disposing a distal end portion of thesurgical stapling apparatus into a second intestinal section; actuatingthe wound treatment material dispersion system to dispense woundtreatment material onto at least one of the first and the secondintestinal sections; and approximating the anvil assembly toward thetubular body portion.

The method may further include the steps of dispensing a first part of atwo-part wound treatment material from a first set of ejection portsformed in the nozzle of the wound treatment material dispersion system;and dispensing a second part of the two-part wound treatment materialfrom a second set of ejection ports formed in the nozzle of the woundtreatment material dispersion system. The method may further include thestep of mixing the first and second part of the two-part wound treatmentmaterial. The first and second parts of the two-part wound treatmentmaterial may be dispensed in a radially outward direction.

The method ma further include the step of dispensing a fluid from thenozzle of the wound treatment material dispersion system, in a directiontransverse to the paths of dispersion of the first and second parts ofthe wound treatment material. The fluid may be dispensed from the nozzlein a substantially proximal direction.

The method may further include the steps of ejecting a first fluid froma proximal set of ejection ports; and ejecting a second fluid from adistal set of ejection ports. The method may further include the stepsof delivering the first fluid through a first conduit to the first setof ejection ports, from a first source of the first fluid; anddelivering the second fluid through a second conduit to the second setof ejection ports from a second source of a second fluid.

The two-part wound treatment material may be selected from the groupconsisting of a two-part bio-adhesive and a two-part sealant.

The approximation assembly may include an inner rod member defining alumen therethrough; a threaded rod member operatively associated with aproximal end of the inner rod member, wherein the treaded rod memberthreadingly engages the fixed handle member; a knob member operativelyconnected to a proximal end of the threaded rod member; and a connectionmember operatively connected proximate to a distal end of the inner rodmember. The nozzle of the wound treatment material dispersion system maybe operatively associated with the distal end of the inner rod member.

The connection member may include windows formed on opposite sidesthereof. The windows of the connection member may be in registrationwith the plurality of proximal ejection ports and the plurality ofdistal ejection ports of the manifold.

According to another aspect of the present disclosure, a surgicalstapling apparatus, for dispensing wound treatment material to a targetsurgical site is provided. The apparatus includes a handle assembly; atleast one pivotable actuating handle member connected to the handleassembly; a tubular body portion extending from the handle assembly; ananvil assembly including a stem and an anvil member supported on one endof the stem; a staple pusher member operatively supported on a distalend of the tubular body portion; connection means operatively disposedwithin the tubular body portion, the connection means being configuredand adapted to operatively engage a second end of the stem; and anampoule operatively disposed within the connection means. The ampoulecontains a quantity of wound treatment material therein, and whereinduring a surgical procedure, the wound treatment material is dispensedfrom the ampoule.

The ampoule may include a body portion defining a lumen for retainingthe wound treatment material, and a plunger slidably disposed within thelumen. Accordingly, in use, as the plunger is axially displaced throughthe lumen, the wound treatment material contained therein is dispensedfrom an aperture formed in the body portion.

The connection means may include a trocar defining a cavity thereinconfigured and dimensioned to receive the ampoule therein. The trocardefines at least one port in fluid communication with the aperture ofthe body portion of the ampoule. Accordingly, in use, as the woundtreatment material is dispensed from the aperture of the body portionthe wound treatment material is conducted through the at least one portof the trocar. Each port may be angled in a proximal direction.

The surgical stapling apparatus may further include a drive cableextending through the surgical stapling apparatus and engaging theplunger of the ampoule. In use, movement of the drive cable in a distaldirection results in movement of the plunger in the distal direction todispense the wound treatment material therefrom.

According to yet another aspect of the present disclosure, a surgicalstapling apparatus for applying an annular array of staples, and a woundtreatment material or at least one component of a wound treatmentmaterial is provided. The surgical stapling apparatus includes an anvilmember positionable on a distal end of the stapling apparatus, the anvilmember including an anvil stem adapted for connecting the anvil memberto the distal end of the stapling apparatus, the anvil stem including alumen extending therethrough, and at least one hole formed in an outersurface thereof and in fluid communication with the lumen; and afastener assembly positioned adjacent a distal end of the staplingapparatus, the fastener assembly and anvil member being juxtaposablerelative to each other. The fastener assembly includes a plurality ofsurgical staples individually disposed within staple slots provided inthe fastener assembly; and a staple pusher member for firing thesurgical staples from the individual staple slots and against the anvilmember. The surgical stapler apparatus further includes a woundtreatment material applicator assembly operatively associated with thestapler apparatus.

The applicator assembly includes at least one reservoir for storing awound treatment material or at least one component of a wound treatmentmaterial; and a conduit system providing fluid communication between theat least one reservoir and the anvil stem of the anvil member, whereinthe wound treatment material or the at least one component thereof flowsfrom the at least one reservoir through the conduit system, the lumen ofthe anvil stem and dispenses out through the at least one hole formed inthe anvil stem to an area substantially between the anvil member and thefastener assembly.

The conduit system may include a connection means defining a boretherethrough, wherein the connection means is adapted to engage theanvil stem of the anvil member such that the bore thereof is in fluidcommunication with the lumen of the anvil stem.

The at least one reservoir may be compressible. The at least onereservoir may be compressed before, during or after firing of thesurgical stapling apparatus to expel the wound treatment materialtherefrom. The surgical stapling apparatus further includes a woundtreatment material contained within the at least one reservoir.

The surgical stapling apparatus may further include a tubular bodyportion, wherein the fastener assembly is disposed at a distal end ofthe body portion; and means for actuating the fastener assembly to expelthe annular array of staples therefrom.

The anvil member may be disposed at a distal end of the body portion andpositioned opposite the fastener assembly. The anvil member may beadapted to clinch the staples in tissue upon expulsion of the staples.

The surgical stapling apparatus may further include means for advancingat least one of the staple pusher member and the anvil member from anextended position away from the other of the members to a positionadjacent the other member. The surgical stapling apparatus may stillfurther include a flexible member positioned coaxially within thetubular body portion, the flexible member being operatively coupled at aproximal end to the advancing means and at a distal end to the at leastone member. The fastener assembly may be positioned on the distal end ofthe tubular body portion, and the advancing means may move the anvilmember from the extended position away from the staple pusher member tothe position adjacent the fastener assembly.

The advancing means may include a grip member positioned at a proximalend of the apparatus. The conduit system may include a connection meansdefining a bore therethrough. The connection means may be adapted toengage the anvil stem of the anvil member such that the bore thereof isin fluid communication with the lumen of the anvil stem.

It is envisioned that the at least one reservoir is compressible. The atleast one reservoir may be compressed before, during or after firing ofthe surgical stapling apparatus to expel the wound treatment materialtherefrom. The surgical stapling apparatus may further include a woundtreatment material contained within the at least one reservoir. Thereservoir is desirably disposed between the actuating means and the gripmember. Accordingly, movement of the actuating means toward the gripmember results in the compression of the reservoir.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing features of the present disclosure will become morereadily apparent and may be understood by referring to the followingdetailed description of an illustrated embodiment of a surgicalinstrument, apparatus or structure, taken in conjunction with theaccompanying drawings, in which:

FIG. 1 illustrates a perspective view of a surgical stapling apparatusaccording to an embodiment of the present disclosure;

FIG. 2 is a longitudinal cross-sectional view of the surgical staplingapparatus of FIG. 1;

FIG. 3 is a side view of an approximation assembly of the surgicalstapling apparatus of FIGS. 1 and 2;

FIG. 4 is a perspective view of a drive assembly of the surgicalstapling apparatus of FIGS. 1-3;

FIG. 5 is an enlarged perspective view of the indicated area of detailof FIG. 1;

FIG. 6 is an enlarged perspective view of the indicated area of detailof FIG. 5;

FIG. 7 is a perspective view of a sprayer tip assembly of the surgicalstapling apparatus of FIGS. 1-6;

FIG. 8 is a distal end view of the sprayer tip assembly of FIG. 7;

FIG. 9 is a cross-sectional view of the sprayer tip assembly of FIGS. 7and 8 as taken through 9-9 of FIG. 8;

FIG. 10 is a schematic perspective view of the distal end of thesurgical stapling apparatus of FIGS. 1-9 illustrating the placementthereof in a target surgical site;

FIG. 11 is a schematic perspective view of the distal end of thesurgical stapling apparatus of FIGS. 1-10 illustrating the dispensing ofwound treatment material therefrom;

FIG. 12 illustrates a perspective view of a surgical stapling apparatusaccording to another embodiment of the present disclosure;

FIG. 13 is an exploded perspective view of the distal end of thesurgical stapling apparatus of FIG. 12;

FIG. 14 is a longitudinal cross-sectional view of the distal end of thesurgical stapling apparatus of FIG. 13;

FIG. 15 is a perspective view of schematic illustration of a woundtreatment material dispensing system according to the presentdisclosure;

FIG. 16 is a longitudinal cross-sectional view of the wound treatmentmaterial dispensing system of FIG. 15, with a plunger thereof in a firstposition;

FIG. 17 is a longitudinal cross-sectional view of the wound treatmentmaterial dispensing system of FIGS. 15 and 16, with the plunger thereofin a second position and illustrating the dispensing of wound treatmentmaterial therefrom;

FIG. 18 is a schematic illustration of a distal end of the surgicalstapling apparatus of FIG. 12, including the wound treatment materialdispensing system of FIGS. 15-17 operatively associated therewith,illustrating the dispersing of wound treatment material therefromaccording to a method of the present disclosure;

FIG. 19 is a longitudinal cross-sectional view of the distal end of thesurgical stapling apparatus of FIG. 14, illustrating the displacement ofthe drive cable to dispense the wound treatment material from the woundtreatment material dispensing system;

FIG. 20 is a schematic illustration of a distal end of the surgicalstapling apparatus of FIG. 12, illustrating the removal of the woundtreatment material dispensing system of FIGS. 15-17 from the distal endof the surgical stapling apparatus of FIG. 12;

FIG. 21 illustrates a perspective view of a surgical stapling apparatusaccording to an alternate embodiment of the present disclosure;

FIG. 22 is a perspective view of the surgical stapling apparatus of FIG.21 illustrating an exemplary method of dispensing the wound treatmentmaterial from the stem of the anvil assembly; and

FIG. 23 is a schematic illustration of the surgical stapling apparatusof FIGS. 21 and 22 depicting the dispensing of wound treatment materialfrom a stem of an anvil assembly.

DETAILED DECRIPTION OF THE EMBODIMENT

Embodiments of the presently disclosed surgical stapling apparatus willnow be described in detail with reference to the drawing figures whereinlike reference numerals identify similar or identical elements. As usedherein and as is traditional, the term “distal” refers to that portionwhich is furthest from the user while the term “proximal” refers to thatportion which is closer to the user.

With reference to FIGS. 1 and 2, surgical stapling apparatus 10 includesa tubular body portion 20 and an actuator that desirably comprises anactuator or handle assembly 12. In the embodiment shown, handle assembly12 has a fixed handle member 14 and a pivotable handle member 16. Incertain embodiments, tubular body portion 20 is desirably constructed soas to have a straight shape along at least a portion of its length. Itis also envisioned that tubular body portion 20 is constructed so as tobe curved along at least a portion of its length, or in otherembodiments, tubular body portion 20 may be flexible to bend to anyconfiguration. Body portion 20 houses a staple pusher member 22. Bodyportion 20 includes an annular array of staple pockets 24 (best seen inFIG. 5), which may be housed in a staple cartridge, for retainingstaples (not shown) therein.

Staple pusher member 22 includes a member movably mounted in bodyportion 20, as is known in the art. Staple pusher member 22 may includefingers extending axially in alignment with the staples in thecartridge. The body portion 20 also desirably houses a blade or blades,preferably having an annular shape. Positionable opposite body portion20 is an anvil assembly 26 including an anvil member 26 a and a stem 26b extending from the anvil member 26 a which is detachably connected toconnection member 32 of approximation assembly 30. An exemplary anvilassembly 26 for use with stapling apparatus 10 is disclosed in certainembodiments of commonly assigned U.S. Pat. No. 5,119,983, issued Jun. 9,1992, and U.S. Pat. No. 5,718,360, which are hereby incorporated intheir entirety herein by reference. In other embodiments, anvil assembly26 is not detachable from connection member 32.

The anvil assembly 26 is positionable opposite the tubular body portion20 for movement towards and away from tubular body portion 20. However,it is of course contemplated that anvil assembly 26 may be positioned atthe distal end of tubular body portion 20 and the staple pusher member22 and the array of staples may be positioned opposite anvil assembly 26for movement towards and away from anvil assembly 26. Such aconstruction is to be considered within the scope of the presentdisclosure.

The stapling apparatus 10 includes an approximation assembly 30 formoving the anvil assembly 26 toward and away from tubular body portion20. As seen in FIG. 3, approximation assembly 30 includes a connectionmember 32, an inner rod member 40, a threaded rod member 42, and a knobmember 18. Connection member 32 includes a distal end 32 a configuredand adapted to releasably engage stem 26 b (see FIG. 2) of an anvilassembly 26. The connection member 32 may be integrally formed withinner rod member 40 or, as shown in FIG. 3, may have a proximal end 32 boperatively connected to a distal end 40 a of inner rod member 40.Proximal portion 32 b of connection member 32 includes windows 34 a, 34b formed on either side thereof. Inner rod member 40 includes a proximalend 40 b which may be operatively connected to a distal end 42 a ofthreaded rod member 42 or, in the alternative, extends completelythrough threaded rod member 42. Knob member 18 is desirably secured to aproximal end 42 b of threaded rod member 42.

As seen in FIG. 4, the surgical stapling apparatus 10 includes a driveassembly 50. Drive assembly 50 includes a bushing 52 defining a lumen 53(shown in phantom) therethrough, a pair of opposed stems 54 a, 54 bextending radially from bushing 52, and a nub 56 extending radially frombushing 52. Desirably, stems 54 a and 54 b slidably engage respectiveelongate slots 14 a, 14 b formed in fixed handle member 14 (see FIGS. 1and 2). Drive assembly 50 further includes a pair of drive arms 58 a, 58b operatively connected to bushing 52 and extending axially therefrom.Threaded rod member 42 and/or inner rod member 40 of approximationassembly 30 slidably extends through lumen 53 of bushing 52.

As will be described in greater detail below, a stem 16 a extending froma proximal end portion of actuating handle member 16 operatively engagesnub 56 of bushing 52. This is best seen in FIGS. 1 and 2. In thismanner, as actuating handle member 16 is squeezed or approximated towardfixed handle member 14, stem 16 a of actuating handle member 16 engagesor presses against nub 56 of bushing 52 to move or force drive assembly50 in a distal direction. Drive assembly 50 is maintained in asubstantially linear path due to the sliding engagement of opposed stems54 a and 54 b of bushing 52 in elongate slots 14 a, 14 b of fixed handlemember 14. Movement of drive assembly 50 in a distal direction causes adistal ends 59 a, 59 b of drive arms 58 a, 58 b to actuate staple pushermember 22 to thereby drive out the staples retained therein. Othermechanisms for driving staples may be used, such as hydraulics,linkages, cables, etc.

Desirably, as seen in FIGS. 1 and 2, surgical stapling apparatus 10desirably includes a biasing member 60 for returning drive assembly 50and/or actuating handle member 16 to the pre-actuated or pre-firedposition. Biasing member 60 may include a compression spring disposedbetween a proximal facing surface of fixed handle member 14 and a distalfacing surface 52 a (see FIG. 4) of bushing 52. In this manner, whenactuating handle member 16 is squeezed, bushing 52 is moved distally andbiasing member 60 is compressed or biased. Accordingly, when actuatinghandle member 16 is released, biasing member 60 expands and movesbushing 52 in a proximal direction which in turn returns actuatinghandle member 16 to an un-squeezed condition.

In a typical method of operation, apparatus 10 is positioned within atubular organ in the body of the patient and the ends of the organ to bejoined are positioned in the gap between tubular body portion 20 andanvil assembly 26. As is conventional, the ends of the organ may besecured over anvil assembly 26 and tubular body portion 20 by a pursestring suture prior to approximation of anvil assembly 26 in relation totubular body portion 20 (see FIG. 11). In embodiments having adetachable anvil assembly, the tubular body portion 20 and anvilassembly 26 are separately positioned within the tubular organ ends andreconnected after the purse string sutures are applied.

In order to approximate anvil assembly 26 towards tubular body portion20, knob member 18 is rotated to displace approximation assembly 30 in aproximal direction relative to handle assembly 12. This draws anvilassembly 26 into position adjacent tubular body portion 20 and locatesthe ends of the tissue between these two members. Once the properdistance is set between anvil assembly 26 and tubular body portion 20,actuating handle member 16 is pivoted or squeezed to move drive assembly50 in a distal direction, actuate staple pusher member 22 and drive thestaples through the tissue. The staples are driven against anvil member26 a of anvil assembly 26 and the tissue located inwardly of the staplesis desirably cut with a blade, to complete the circular anastomosis ofthe tubular organ.

Turning now to FIGS. 5-9, surgical stapling apparatus 10 includes awound treatment material dispersion system 100 configured to disperse(e.g., spray, eject, squeeze, dispense, etc.) wound treatment material“W” onto a surface of tissue “T”. Wound treatment material dispersionsystem 100 includes at least one conduit, such as first conduit 102,second conduit 104, and third conduit 106 (FIGS. 1, 2 and 7-9), fortransmitting fluid through stapling apparatus 10 to a dispersion head ornozzle 110. Desirably, nozzle 110 is operatively associated withapproximation assembly 30. For example, as shown in FIGS. 5 and 6,nozzle 110 is disposed in connection member 32. Nozzle 110 includes amanifold 112 configured and adapted to receive and dispense the fluidcommunicated thereto from conduits 102, 104 and 106.

Conduits 102, 104 and 106 extend through the lumen of inner rod member40 and extend out a proximal end of surgical stapling apparatus 10. Aproximal end of each conduit 102, 104 and 106 is desirably fluidlyconnected to at least one source of fluid. In certain preferredembodiments, each conduit 102, 104 and 106 is fluidly connected to arespective source of fluid “S1, S2 and S3” (see FIG. 2). Source of fluid“S1” is connected to conduit 102, source of fluid “S2” is connected toconduit 104, and source of fluid “S3” is connected to conduit 106. Inother embodiments, fewer or more than three conduits and/or sources areused. In other embodiments, one or more of the sources of fluid arehoused within the stationary handle 14 or tubular body portion 20. Thesource or sources of fluid may also comprise a separate reservoirconnectable to the stationary handle 14 or tubular body portion 20.

Manifold 112 includes a plurality of proximal ejection ports 114 formedpreferably on at least two opposed sides of manifold 112. A distal endof first conduit 102 is in fluid communication with the proximal arrayof ejection ports 114. In this manner, as will be described in greaterdetail below, fluid transmitted from first source “S1” of fluid, throughfirst conduit 102, is dispensable or ejectable from the proximal arrayof ejection ports 114.

Manifold 112 further includes a plurality of distal ejection ports 116formed preferably on at least two opposed sides of manifold 112,adjacent the proximal ejection ports 114. A distal end of second conduit104 is in fluid communication with the distal array of ejection ports116. In this manner, as will be described in greater detail below, fluidtransmitted from second source “S2” of fluid, is conducted throughsecond conduit 104, and dispensable or ejectable from the distal arrayof ejection ports 116. In other embodiments, one or more sources offluid are in communication with the same ejection port or portion.

A distal end portion 115 of manifold 112 is angled to define a pair ofangled surfaces 115 a, as best seen in FIG. 9. Each angled surface 115 aof distal end portion 115 of manifold 112 is desirably angled at fromabout 1° to about 90° relative to a longitudinal “X” axis, desirablyangled at about 15° relative to the longitudinal “X” axis.

Nozzle 110 further includes a cap 120 operatively connected to thedistal end of manifold 112. Cap 120 is operatively connected to manifold112 in such a manner so as to define a channel or space 122 between aproximal facing inner surface 120 a of cap 120 and a distal-most surface112 a of manifold 112. Additionally, cap 120 includes a pair of angledinner surfaces 121 a, 121 b extending proximally from inner surface 120a. Angled inner surfaces 121 a, 121 b complement the pair of angledsurfaces 115 a of manifold 112. Preferably, channel 122 extends downangled annular inner surfaces 121 a, 121 b and down the pair of angledsurfaces 115 a of distal end portion 115 of manifold 112.

Third conduit 106 extends through manifold 112 and includes a distal endwhich is in fluid communication with channel 122. In this manner, aswill be described in greater detail below, fluid transmitted from thethird source “S3” of fluid, through third conduit 106, is dispensable orejectable from channel 122 disposed between the inner surface 121 a ofcap 120 and the outer surface 115 a of manifold 112. Nozzle 110 isdisposed in connection member 32 so that the ejection ports 114 and 116,as well as proximal end of cap 120 are disposed in window 34 a, 34 b.

In use, as will be described in greater detail below, when a first fluidis dispensed from the plurality of proximal ejection ports 114 and asecond fluid is dispensed from the plurality of distal ejection ports116, the first and second fluids are mixed together by the third fluiddispensed from channel 122 which re-directs the path of dispersion ofthe second fluid into and across the path of dispersion of the firstfluid. In other embodiments, the channel 122 may be eliminated and thesurfaces of the dispersion system direct the fluid or fluids so as tomix them, or a member is movably mounted on distal end of the dispersionsystem, for mixing fluids.

The first source “S1” delivers a first fluid “W1” (e.g., a first part ofa multi-part wound treatment material “W”) through first conduit 102 toproximal ejection ports 114. The second source “S2” delivers a secondfluid “W2” (e.g., a second part “W2” of the multi-part wound treatmentmaterial “W”) through second conduit 104 to distal ejection ports 116.The third source “S3” delivers a third fluid, which may comprise gas “F”(e.g., air, CO₂, etc.) through third conduit 106 to channel 122. As willbe described in greater detail below, the third fluid “F” functions tomix the first part “W1” with the second part “W2” of the wound treatmentmaterial “W” and to also direct the wound treatment material “W” towardthe target tissue. In certain preferred embodiments, one or more of thefluid sources comprise cartridges removably connected to the handleassembly and which house the fluid. The cartridge or cartridges may bedisposed within the handle assembly.

The delivery of the wound treatment material “W1, W2 and W3” may beaccomplished utilizing one or more plungers in the conduits 102, 104and/or 106, gas pressure, balloons, or pressure members for squeezingthe conduits 102, 104, 106 to dispense the wound treatment material. Thehandle assembly includes a button, trigger or lever for actuating thedelivery of the wound treatment material.

It is contemplated that the wound treatment material “W” is any materialfor joining, healing, sealing or otherwise treating tissue. In apreferred embodiment, the wound treatment material is a bio-compatiblesealant, including, and not limited, to sealants which cure upon tissuecontact, sealants which cure upon exposure to ultraviolet (UV) light,sealants which are multiple part systems, such as two-part systems,which are kept isolated from one another and are combined or anycombinations thereof. Any known suitable adhesive may be used. In oneembodiment, it is contemplated that such sealants and/or adhesives arecurable. For example, sealants may have a cure time of from about 10 to15 seconds may be used. In preferred embodiments, the sealant and/oradhesive is a bioabsorbable and/or bio-resorbable material. In anotherembodiment, it is contemplated that a sealant and/or adhesive having acure time of about 30 seconds may be used. It is further envisioned thatwound treatment material “W” may be a pre-cured adhesive or sealant. Thepre-cured adhesive or sealant may react with the moisture and/or heat ofthe body tissue to thereby activate the sealing and/or adhesiveproperties of the sealant or adhesive.

In certain preferred embodiments, the wound treatment material comprisesa sealant. Such a sealant is desirably a PEG-based material. Examples ofclasses of materials useful as the sealant and/or adhesive includeacrylate or methacrylate functional hydrogels in the presence of abiocompatible photoinitiator, alkyl-cyanoacrylates, isocyanatefunctional macromers with or without amine functional macromers,succinimidyl ester functional macromers with amine or sulfhydrylfunctional macromers, epoxy functional macromers with amine functionalmacromers, mixtures of proteins or polypeptides in the presence ofaldehyde crosslinkers, Genipin, or water-soluble carbodimides, anionicpolysaccharides in the presence of polyvalent cations, etc.

Some specific materials which may be utilized include isocyanateterminated hydrophilic urethane prepolymers derived from organicpolyisocyanates and oxyethylene-based diols or polyols, including thosedisclosed in U.S. Pat. Nos. 6,702,731 and 6,296,607 and U.S. PublishedPatent Application No. 2004/0068078; alpha-cyanoacrylate based adhesivesincluding those disclosed in U.S. Pat. No. 6,565,840; alkyl ester basedcyanoacrylate adhesives including those disclosed in U.S. Pat. No.6,620,846; adhesives based on biocompatible cross-linked polymers formedfrom water soluble precursors having electrophilic and nucleophilicgroups capable of reacting and cross-linking in situ, including thosedisclosed in U.S. Pat. No. 6,566,406; two part adhesive systemsincluding those based upon polyalkylene oxide backbones substituted withone or more isocyanate groups in combination with bioabsorbable diaminecompounds, or polyalkylene oxide backbones substituted with one or moreamine groups in combination with bioabsorbable diisoycanate compounds asdisclosed in U.S. Published Patent Application No. 2003/0032734, thecontents of which are incorporated by reference herein; and isocyanateterminated hydrophilic urethane prepolymers derived from aromaticdiisocyanates and polyols as disclosed in U.S. Published PatentApplication No. 2004/0115229, the contents of which are incorporated byreference herein.

It is envisioned and within the scope of the present disclosure thatwound treatment material “W” may include one or a combination ofadhesives, hemostats, sealants, or any other tissue or wound-treatingmaterial. Surgical biocompatible wound treatment materials “W”, whichmay be used in accordance with the present disclosure, include adhesiveswhose function is to attach or hold organs, tissues or structures,sealants to prevent fluid leakage, and hemostats to halt or preventbleeding. Examples of adhesives which can be employed include proteinderived, aldehyde-based adhesive materials, for example, thecommercially available albumin/glutaraldehyde materials sold under thetrade designation BioGlue™ by Cryolife, Inc., and cyanoacrylate-basedmaterials sold under the trade designations Indermil™ and Derma Bond™ byTyco Healthcare Group, LP and Ethicon Endosurgery, Inc., respectively.Examples of sealants, which can be employed, include fibrin sealants andcollagen-based and synthetic polymer-based tissue sealants. Examples ofcommercially available sealants are synthetic polyethylene glycol-based,hydrogel materials sold under the trade designation CoSeal™ by CohesionTechnologies and Baxter International, Inc. Examples of hemostatmaterials, which can be employed, include fibrin-based, collagen-based,oxidized regenerated cellulose-based and gelatin-based topicalhemostats. Examples of commercially available hemostat materials arefibrinogen-thrombin combination materials sold under the tradedesignations CoStasis™ by Tyco Healthcare Group, LP, and Tisseel™ soldby Baxter International, Inc. Hemostats herein include astringents,e.g., aluminum sulfate, and coagulants.

The medicament may include one or more medically and/or surgicallyuseful substances such as drugs, enzymes, growth factors, peptides,proteins, dyes, diagnostic agents or hemostasis agents, monoclonalantibodies, or any other pharmaceutical used in the prevention ofstenosis.

Wound treatment material “W” may include visco-elastic film formingmaterials, cross-linking reactive agents, and energy curable adhesives.It is envisioned that wound treatment material “W”, and in particular,adhesive may be cured with the application of water and/or glycerinthereto. In this manner, the water and/or glycerin cure the adhesive andhydrate the wound.

It is envisioned that wound treatment material “W” may be a relativelylow viscosity fluid or liquid such that the wound treatment material “W”may freely flow through first and second conduits 102, 104 and outthrough proximal ejection ports 114 and distal ejection ports 116 ofmanifold 112, respectively. It is further envisioned that woundtreatment material “W” may include a fine powder of particulatematerial.

It is further contemplated that wound treatment material “W” mayinclude, for example, compositions and/or compounds which accelerate orbeneficially modify the healing process when particles of thecomposition and/or compound are applied to or exposed to a surgicalrepair site. For example, the wound treatment material “W” may be atherapeutic agent which will be deposited at the repair site. Thetherapeutic agent can be chosen for its antimicrobial properties,capability for promoting repair or reconstruction and/or new tissuegrowth. Antimicrobial agents such as broad spectrum antibiotic(gentamycin sulfate, erythromycin or derivatized glycopeptides) whichare slowly released into the tissue can be applied in this manner to aidin combating clinical and sub-clinical infections in a tissue repairsite. To promote repair and/or tissue growth, wound treatment material“W” may include one or several growth promoting factors, e.g.,fibroblast growth factor, bone growth factor, epidermal growth factor,platelet derived growth factor, macrophage derived growth factor,alveolar derived growth factor, monocyte derived growth factor,magainin, and so forth. Some therapeutic indications are: glycerol withtissue or kidney plasminogen activator to cause thrombosis, superoxidedimutase to scavenge tissue damaging free radicals, tumor necrosisfactor for cancer therapy or colony stimulating factor and interferon,interleukin-2 or other lymphokine to enhance the immune system.

With reference to FIGS. 1-10, and particularly FIG. 10, an exemplarymethod of using and operating surgical stapling apparatus 10 is shownand described. In operation, anvil assembly 26 is introduced into theoperative site and a first organ or tissue to be joined or anastomosedis sutured around anvil assembly 26 by a purse string suture. Next, asseen in FIG. 10, the distal end of surgical stapling apparatus 10 isintroduced into the operative site and sutured to a second organ ortissue “T” by a purse string suture “P” which is to be joined oranastomosed to the first organ or tissue. Desirably, the second organ ortissue “T” is sutured around inner rod member 40 such that the pursestring suture “P” is located proximally of nozzle 100.

With anvil assembly 26 and the distal end of surgical stapling apparatus10 sutured into position stem 26 b of anvil assembly 26 is coupled toconnection member 32 of surgical stapling apparatus 10. Either prior toor after the coupling of stem 26 b of anvil assembly 26 to connectionmember 32 of surgical stapling apparatus 10, wound treatment materialdispensing system 100 is activated to dispense wound treatment material“W” onto the second organ or tissue “T”, by manipulating a button,lever, or trigger on handle assembly 12.

In particular, as seen in FIGS. 9 and 10, first part “W1” of amulti-part wound treatment material “W” is conducted from the firstsource of fluid “S1”, through first conduit 102, for dispersion and/orejection from the plurality of proximal ejection ports 114 of manifold112. A second part “W2” of the multi-part wound treatment material “W”is conducted, from the second source of fluid “S2”, through secondconduit 104, for dispersion and/or ejection from the plurality of distalejection ports 116 of manifold 112. As seen in FIG. 9, third fluid “F”(e.g., air, CO₂, etc.) is conducted from the third source of fluid “S3”,through third conduit 106, for dispensing and/or ejection from channel122. Third fluid “F” functions to re-direct the path of dispersion ofsecond part “W2” of wound treatment material “W” into and across thepath of dispersion of first part “W1” of wound treatment material “W”.Third fluid “F” also functions to mix the second part “W2” of woundtreatment material “W” with the first part “W1” of wound treatmentmaterial “W”. The third fluid “F” directs the mixed wound treatmentmaterials “W1, W2” in a substantially proximal direction against thesecond organ or tissue “T”. Desirably, the fluids “W1, W2” and “F” aredispensed through their respective conduits about simultaneously.

Desirably, first part “W1” of wound treatment material “W” is afirst-part of a multi-part sealant and second part “W2” of woundtreatment material “W” is a second-part of the multi-part sealant.Activation of the sealant is achieved upon mixing of the first andsecond parts together at the desired and/or appropriate time during thesurgical procedure. Premature mixing of the first and second parts ofthe two-part sealant may result in premature curing, clogging or gummingup of components of surgical stapling apparatus 10 and the like.Accordingly, wound treatment material dispersion system 100 maintainsthe first and second parts of the two-part sealant separate from oneanother until the first and second parts are ejected from nozzle 110.

With wound treatment material “W” dispensed onto the second organ ortissue “T” and with stem 26 b of anvil assembly 26 coupled to connectionmember 32 of surgical stapling apparatus 10, anvil assembly 26 isapproximated toward staple pusher member 22 by rotating knob member 18.Rotation of knob member 18 in a first direction causes approximationassembly 30 to move in a proximal direction thereby drawing anvil member26 a of anvil assembly 26 into position adjacent staple pusher member 22and to locate the ends of the tissue between these two members. Knobmember 18 is rotated until the desired and/or necessary distance betweenanvil member 26 a and staple pusher member 22 has been achieved.Desirably, the two opposed tissues are brought into contact with oneanother.

Once the proper distance is set between anvil member 26 a of anvilassembly 26 and staple pusher member 22, surgical stapling apparatus 10is fired by squeezing, e.g., pivoting, actuating handle member 16 towardfixed handle member 14 (see FIGS. 1 and 2). In so doing, stem 16 a ofactuating handle member 16 presses against nub 56 of bushing 52 of driveassembly 50 and causes drive assembly 50 to move in a distal direction.As discussed above, movement of drive assembly 50 in a distal directionresults in compression of biasing member 60 and movement of drive arms58 in a distal direction to actuate staple pusher member 22. As aresult, the staples are driven out of or ejected from body portion 20,through the tissue or organ, and against the anvil member 26 a tocomplete the circular anastomosis of the tubular organ.

Following firing of surgical stapling apparatus 10, actuating handlemember 16 may be released. Release of actuating handle member 16 allowsfor biasing member 60 to expand, thereby moving drive assembly 50 and,in particular bushing 52, in a proximal direction. As bushing 52 movesin a proximal direction, nub 56 thereof presses against stem 16 a ofactuating handle member 16 causing actuating handle member 16 to returnto the un-squeezed or un-approximated condition.

Desirably, application of wound treatment material “W” to theanastomosis site may help to reduce the incidence of anastomotic leakageby sealing the surfaces of the organs and/or tissues of the anastomosisagainst one another. It is further envisioned that application of woundtreatment material “W” to the anastomosis site may help to adhere theanastomosed ends of the organs and/or tissues to one another.

Desirably, in accordance with an embodiment of the present disclosure,surgical stapling apparatus 10 may include an annular knife blade (notshown) operatively associated therewith. Desirably, the annular knifeblade is disposed radially inwardly of the annular array of staplepockets 24, but outwardly of inner rod member 40. A distal end of theannular knife blade includes a cutting edge for severing the tissuelocated radially inwardly of the annular knife blade from the tissuelocated radially outwardly of the annular knife blade. Desirably, inoperation, as surgical stapling apparatus 10 is fired to drive thestaples through the layers of tissue, the annular knife blade issimultaneously advanced to sever the portion of tissue disposed radiallyinwardly of the annular knife from the remaining tissue.

In further embodiments, the manifold 112 includes one array of ports incommunication with a source of fluid “S1”. The channel 122 and angledsurfaces 121 a and 121 b are utilized to dispense a second fluid fromsource “S2”. Alternatively, a one part material is dispensed through thearray of ports and the channel 122 and angled surfaces 121 a and 121 bare utilized to dispense a fluid “F” (such as CO₂ gas or air) fordirecting the fluid dispensed through the array of ports. In furtherembodiments, the manifold 112 does not include an array of ports and thechannel 122 and angled surfaces 121 a and 121 b are used to dispense aone part material.

In further embodiments, the wound treatment material dispersion system100 is incorporated into a device with a tubular body portion and anvilassembly, but without the deployment of staples. The wound treatmentmaterial is relied upon to join the generally tubular organ portions.

Referring now in specific detail to FIG. 12 a surgical staplingapparatus employing structure for applying a dispersible wound treatmentmaterial according to an alternate embodiment of the present disclosureis generally designated as 200. Apparatus 200 includes a handle assembly202 having at least one pivotable actuating handle member 204, andfurther includes advancing means 206 a rotatable grip member 209.

Extending from handle assembly 202, there is provided a tubular bodyportion 208 which may be constructed so as to have a curved shape alongat least a portion of its length. Tubular body portion 208 may also bestraight, or in other embodiments, tubular body portion 208 may beflexible to bend to any configuration. Body portion 208 terminates in astaple pusher member 210. Staple pusher member 210 includes an annulararray of staples 214. Positioned opposite staple pusher member 210 thereis provided an anvil assembly 226 including an anvil member 230 which isconnected to apparatus 200 by stem 228 at connection means 240. Anvilassembly 226 and staple pusher member 210 are disclosed in commonlyassigned U.S. Pat. No. 5,119,983, issued Jun. 9, 1992, which isincorporated herein by reference.

While apparatus 200 is shown and described as utilizing a staple pushermember having an annular array of staples positioned on the tubular bodyportion, and having the anvil member positioned opposite the staplepusher member for movement towards and away from the staple pushermember, it is of course contemplated that the anvil member may bepositioned on the tubular body portion and the staple pusher member andarray of staples be positioned opposite the anvil member for movementtowards and away from the anvil member. Such a construction is to beconsidered within the scope of the present disclosure.

In operation, apparatus 200 is positioned within a tubular organ in thebody of the patient and the ends of the organ to be joined arepositioned in the gap between staple pusher member 210 and anvilassembly 226 so that anvil assembly 226 is fully extended. As isconventional, the ends of the organ may be secured over anvil assembly226 and staple pusher member 210 by a purse string suture prior toapproximation of anvil assembly 226 in relation to staple pusher member210. With anvil assembly 226 and staple pusher member 210 purse stringsutured, stem 228 of anvil assembly 226 is coupled to connection means240 disposed within staple pusher member 210.

In order to approximate anvil assembly 226 towards staple pusher member210, grip member 209 is rotated to displace an inner rod member (notshown) in a proximal direction. This draws anvil assembly 226 intoposition adjacent staple pusher member 210 and locates the ends of thetissue between these two members.

Once the proper distance is set between anvil assembly 226 and staplepusher member 210 interlock means 232 may be released and actuatinghandles 204 may be pivoted to drive the staples through the tissue andagainst anvil member 230 to complete the circular anastomosis of thetubular organ. Reference may be made to U.S. Pat. No. 5,119,983,previously incorporated herein by reference for a more detaileddescription and discussion of the structure and operation of surgicalstapling apparatus 200.

With reference to FIGS. 13 and 14, staple pusher member 210 of surgicalstapling apparatus 200, is shown and described. Although not shown ordiscussed herein, connection means 240 is connected to an approximationmechanism and pusher 224 is connected to the firing mechanism ofsurgical stapling apparatus, such as, for example, pivotable actuatinghandle members 204 (see FIG. 1).

Staple pusher member 210 includes a housing 220, a pusher 212, anannular knife blade (not shown), a staple guide 214, and a plurality ofstaple 216. As seen in FIG. 14, housing 220 includes an outer housingportion 220 a and an inner housing portion 220 b. Staple guide 214 issupported in the distal end of outer housing portion 220 a and includesan annular array of staple receiving pockets 218 for housing staples216. Pusher 212 is slidably supported in housing 220 between outerhousing portion 220 a and inner housing portion 220 b and is slidablebetween retracted and advanced positions.

An elongated hollow bushing 246 is fixedly retained in inner housingportion 220 b of housing 220. Bushing 246 defines a lumen through whichconnection means 240 reciprocates during approximation and separation ofstaple anvil assembly 226 and staple pusher member 224.

Connection means 240 includes a two-part trocar assembly having a bodyportion 242 defining a longitudinal throughbore 242 a and a trocar 244slidably received within longitudinal throughbore 242 a of body portion242. Desirably, longitudinal throughbore 242 a includes a steppedportion or shoulder 236 (see FIG. 14).

Trocar 244 includes a tip 248 at one end thereof and an annular flange241 at the other end thereof. Tip 248 of trocar 244 extends from adistal end of body portion 242 of the trocar assembly and is movablefrom an advanced position to a retracted position. Desirably, tip 248 issharpened thereby enabling tip 248 to penetrate tissue and the like. Abiasing member, preferably a coil spring 252, is positioned betweenannular flange 241 of trocar 244 and shoulder 236 and urges trocar 244to its retracted position.

Turning now to FIGS. 15-17, trocar 244 forms a part of a wound treatmentmaterial dispersion system, according to an embodiment of the presentdisclosure. Trocar 244 is preferably hollow and is sized to receive anampoule 260 or the like therein. Ampoule 260 includes a body portion 262having a nub 263 extending axially therefrom, and defining a lumen 262 aextending through each of body portion 262 and nub 263. Nub 263 has asmaller cross-sectional dimension than body portion 262 and defines ashoulder 263 a. Ampoule 260 further includes a plunger 264 slidablydisposed within lumen 262 a. Plunger 264 forms a fluid tight seal withthe inner surface of body portion 262. Desirably, wound treatmentmaterial “W” is retained within lumen 262 a of ampoule 260.

As seen in FIGS. 15-17, trocar 244 defines a cavity 229 for selectivelyreceiving ampoule 260 therein. A distal end of cavity 229 defines adistal pocket 229 a configured to receive nub 263 of ampoule 260therein. Pocket 229 a is dimensioned such that a shoulder 263 a ofampoule 260 contacts or engages a corresponding shoulder 229 b formed incavity 229.

Trocar 244 further includes a channel 245 a extending from distal pocket229 a and which branches off into a series of ports 245 b formedradially around tip 248. Preferably, ports 245 b are angled in aproximal direction. Preferably, trocar 244 includes a two-tiered tip 248having a distal-most conical tip 248 a and a proximal-most conical tip248 b. Desirably, ports 235 b are formed between distal-most conical tip248 a and proximal-most conical tip 248 b such that ports 235 b areformed in a proximal surface of distal-most conical tip 248 a. In thismanner, when ampoule 260 is placed within cavity 229 of trocar 244,lumen 262 a of ampoule 260 is in fluid communication with ports 235 b.As seen in FIG. 15, ports 235 b act like a manifold to divide thedispersion of wound treatment material “W” to different radial segmentsaround trocar 244.

In operation, as seen in FIG. 17 and as will be described in greaterdetail below, upon distal advancement of plunger 264 through lumen 262 aof ampoule 260 (in the direction of arrow “A”), wound treatment material“W” is forced through nub 263, into distal pocket 229 a, and out throughports 245 b. It is envisioned that a piston, rod or some other device ormethod (e.g., pneumatic) may be used to advance plunger 264 distallythrough lumen 262 a.

Preferably, as seen in FIGS. 14 and 19, surgical stapling apparatus 200includes a piston or drive cable “C” extending therethrough. Drive cable“C” includes a distal end which contacts and/or engages or isoperatively engaged with plunger 264 of ampoule 260. Desirably, cable“C” is sufficiently flexible to bend and flex through surgical staplingapparatus 200 and sufficiently rigid to transmit forces along the lengththereof. In this manner, as will be discussed in greater detail below,with a distal end of drive cable “C” in operative engagement withplunger 264, as drive cable “C” is distally advance through surgicalstapling apparatus 200, drive cable “C” advances plunger 264 throughlumen 262 a of ampoule 260 to thereby force wound treatment material “W”therefrom.

Turning now to FIGS. 18 and 19, use of the wound treatment materialdispersion system, including trocar 244, of FIGS. 13-17, in connectionwith surgical stapling apparatus 200, is shown and described. Inoperation, anvil assembly 226 is introduced into the operative site andsutured to a first organ or tissue to be joined or anastomosed by apurse string suture. Next, with ampoule 260 positioned within trocar244, the distal end of surgical stapling apparatus 200 is introducedinto the operative site and sutured to a second organ or tissue by apurse sting suture “P” which is to be joined or anastomosed to the firstorgan or tissue. Desirably, the second organ or tissue it sutured totrocar 244 and/or connection means 240 such that purse string “P” islocated proximal of ports 245 b.

With anvil assembly 226 and staple pusher member 210 sutured in place,as seen in FIG. 19, a piston or drive cable “C” of connection means 240is advanced in a distal direction (e.g., in the direction of arrow “A”)to drive plunger 264 through lumen 262 a of ampoule 260 and force woundtreatment material “W” contained therein out through channel 245 a oftrocar 244 and, in turn, out through ports 245 b. Since ports 245 b areangled in a proximal direction, wound treatment material “W” isdispensed onto the second organ or tissue to be anastomosed.

With the second organ or tissue at least partially coated with woundtreatment material “W”, stem 228 of anvil assembly 226 is coupled toconnection means 240 of staple pusher member 210. Anvil assembly 226 isthen approximated towards staple pusher member 210 by rotating gripmember 218 to thereby draw anvil assembly 226 into position adjacentstaple pusher member 210 and locates the ends of the tissue betweenthese two members.

Once the proper distance is set between anvil member 230 and staplepusher member 210, actuating handles 204 may be pivoted to drive thestaples through the tissue or organ and against anvil member 230 tocomplete the circular anastomosis of the tubular organ. Reference may bemade to U.S. Pat. No. 5,119,983, the entire contents of which areincorporated herein by reference, for a more detailed description anddiscussion of the operation of surgical stapling apparatus 200.

According to another method of use, as seen in FIG. 20, followingdispensing of wound treatment material “W” onto the second organ ortissue, trocar 244 is removed from connection means 240 and stem 228 ofanvil assembly 226 is operatively connected or otherwise docked thereto.With anvil assembly 226 operatively connected to connection means 240,anvil assembly 226 is approximated toward staple pusher member 210 andsurgical stapling apparatus 200 is fired as described above.

Desirably, application of wound treatment material “W” to theanastomosis site may help to reduce the incidence of anastomosis leakageby sealing the surfaces of the organs and/or tissues of the anastomosisagainst one another. It is further envisioned that application of woundtreatment material “W” to the anastomosis site may help to adhere theanastomosed ends of the organs and/or tissues to one another.

It is envisioned that wound treatment material “W” may be asubstantially non-viscous fluid or liquid such that the wound treatmentmaterial “W” may freely flow from ports 245 b of trocar 244.

It is provided that a number of different wound treatment materials “W”can be dispensed by trocar 244 of the wound treatment materialapplicator assembly. The wound treatment material dispensed by woundtreatment material applicator assembly can, for example, include anyand/or all of the wound treatment materials disclosed above.

According to an alternate embodiment of the present disclosure, as seenin FIGS. 21 and 22, surgical stapling apparatus 200 further includes awound treatment material applicator assembly 270 for applying woundtreatment material “W” to a target tissue “T” (see FIG. 23). Woundtreatment material “W” may include and is not limited to at least onebiological and/or synthetic biocompatible sealant, hemostat, adhesive,and combinations thereof. Wound treatment material “W” may be applied totarget tissue “T” either before, during or after firing of the annulararray of staples 216 (see FIG. 13). The application of wound treatmentmaterial “W” to a knife cut line and/or staple line can provide short,i.e., temporary, and long-term, i.e., permanent, hemostasis and sealing,and reduce or prevent bleeding along the knife cut line and/or stapleline, while the stapling features provide short and long-term tissuestrength and hemostasis.

If used without staples 216, surgical stapling apparatus 200 provides ananastomosis capable of greater elasticity resulting in lower possibilityof stricture at the site. If used with staples, surgical staplingapparatus 200 provides greater initial strength, with lower possibilityof leakage of bowel contents. Additionally, since knife cut line andstaple line bleeding is reduced or prevented, the surgical staplingapparatus 200 of the present invention makes it possible to expand theapplicable range of specific staple sizes to include thinner or thickerstaples.

As seen in FIGS. 21 and 22, wound treatment material applicator assembly270 includes at least one reservoir 272 fluidly connectable or connectedto a passage 228 b (see FIG. 23) formed in connection means 240.Desirably, reservoir 272 is compressible and is affixed or mounted to apivotable actuating handle member 204 or disposed between actuatinghandle member 204 and grip member 209. Reservoir 272 may be in fluidcommunication with stem 228 of anvil assembly 226 via a conduit 274fluidly connecting reservoir 272 to passage 228 b of stem 228.

In use, wound treatment material applicator assembly 270 supplies woundtreatment material “W”, or a component thereof, to a target surgicalsite upon compression of reservoir 272 between handle member 204 andgrip member 209. In one exemplary embodiment, as seen in FIGS. 21 and22, by moving pivotable actuating handle members 204 towards grip member209, as indicated by arrow “A”, reservoir 272 is squeezed or compressedtherebetween.

Compression of reservoir 272 causes wound treatment material “W”contained therein to be urged through conduit 274 and dispensed viaholes 228 a of anvil stem 228. As seen in FIG. 23, wound treatmentmaterial “W” may be dispensed before or during the staple firingprocedure so that wound treatment material “W” is dispensed along thelength of the staple line and/or along a circular knife cut line andalong the surfaces of target tissues “T” which are to come into contactwith one another. Other methods of initiating the dispensing of thewound treatment material “W” from anvil stem 228 are envisioned, suchas, for example, dispensing of wound treatment material “W” uponactuation of the circular knife, movement of anvil assembly member 226towards the fastener assembly, and the like.

During dispensing, wound treatment material “W” is ejected into or ontothe space between the tissue surfaces clamped between movable anvilmember 230 and staple pusher member 210. Ejection of wound treatmentmaterial “W” occurs by spraying, squirting, and/or foaming. Duringejection of wound treatment material “W” it is preferred that anvil stem228 rotates so that wound treatment material “W” is spread radially overand along the clamped tissue surfaces.

While a single reservoir 272 for containing wound treatment material “W”is shown and described, it is envisioned and within the scope of thepresent disclosure for any number of reservoirs to be fluidly connectedto passage 228 b of stem 228. In such an embodiment, one or a firstreservoir may store one component of wound treatment material “W” andanother or a second reservoir may store a second component of woundtreatment material “W”. Preferably, the first and second reservoirs areidentical and encase or store an equal or appropriate volumetric amountof their respective component of wound treatment material “W” tomaintain a predetermined desired ratio of the first component of thewound treatment material “W” to the second component of the woundtreatment material “W”, which is typically a 1:1 ratio.

Preferably, the wound treatment material “W” formed by the twocomponents is a fibrin glue or a fibrin sealant, which acts as ahemostatic agent and as a tissue adhesive. Fibrin sealant is formed by arapid polymerization process, which occurs when a solution of proteomicclotting factors, such as fibrinogen, comes into contact with a solutionof a proteomic catalyst, such as thrombin. This rapid polymerizationtypically commences within two seconds after the solutions initiallycontact one another, and it typically attains a soft set within tenseconds of contact. Because of the rapid polymerization upon intimateinteraction of fibrinogen and thrombin, it is important and preferableto maintain these two blood proteins separate until applied at theapplication site. Accordingly, in an alternative embodiment the woundtreatment material applicator assembly 270 supplies each blood proteinseparately from the other blood protein by using a separate conduit foreach protein.

It is envisioned that reservoir 272 of applicator assembly 270 maycontain any one or any combination of the wound treatment materials “W”disclosed above.

It is to be understood that the dispensing of wound treatment material“W” can be a fluid spray of any suitable volume, including a mist,applied temporarily, continuously, or continually. Particulate material,e.g. a fine powder is contemplated to be a fluid within the scope ofthis disclosure.

It is envisioned and within the scope of the present disclosure for thewound treatment material “W” to be dispensed, from either surgicalstapling apparatus 100, 200, in an aerosol form. For example, withreference to FIG. 2, third source “S3” may be an aerosol can containinga propellant (e.g., compressed air, CO₂, etc.) therein which is used toatomize the wound treatment material “W” during dispensing of woundtreatment material “W” to the target tissue.

In further embodiments, the conduit 274 is incorporated within tubularbody portion 208 and/or the reservoir 272 is incorporated into the gripmember 206. The conduit 274 shown in FIG. 22 may be connected to thetubular body portion 208 closer to the handle assembly 202, so that theconduit 274 does not interfere with the insertion of the device into apatient or a patient's organs.

It will be understood that various modifications may be made to theembodiments of the presently disclosed surgical stapling apparatus andthe wound treatment material dispersion system described above.Therefore, the above description should not be construed as limiting,but merely as exemplifications of preferred embodiments. Those skilledin the art will envision other modifications within the scope and spiritof the present disclosure.

1. An apparatus for forming an anastomosis between adjacent sections oftissue, comprising: a body portion; an actuation assembly operativelysupported at a proximal end of the body portion; an anvil assemblymovably mounted at a distal end of the body portion for movement towardand away from the body portion; an approximation assembly extendingbetween the body portion and the anvil assembly for moving the anvilassembly toward and away from the body portion; a dispersion assemblyoperatively associated with the approximation assembly, the dispersionassembly including at least one angled surface defining at least onechannel interposed between the anvil assembly and the body portion andbeing configured to dispense a fluid therefrom, wherein the dispersionassembly includes: a manifold having a plurality of ejection ports fordispensing wound treatment material, the channel directing the woundtreatment material across the ejection ports, wherein the ejection portsinclude: a plurality of first ejection ports formed therein fordispensing a first wound treatment material; and a plurality of secondejection ports formed therein for dispensing a second wound treatmentmaterial different from the first wound treatment material; wherein theplurality of first ejection ports and the plurality of second ejectionports are both provided on opposed sides of the manifold; and whereinthe plurality of first ejection ports and the plurality of secondejection ports are radially oriented; and at least one conduit forconducting wound treatment material to the dispersion assembly.
 2. Theapparatus according to claim 1, wherein the at least one conduitincludes: a first conduit having a distal end in fluid communicationwith the plurality of first ejection ports formed in the manifold; and asecond conduit having a distal end in fluid communication with theplurality of second ejection ports formed in the manifold.
 3. Theapparatus according to claim 2, wherein a distal end portion of themanifold is tapered at an angle relative to a longitudinal axis of thebody portion, and the plurality of first ejection ports and theplurality of second ejection ports are disposed in a distal end portionof the manifold.
 4. The apparatus according to claim 3, wherein thedispersion assembly further includes: a cap operatively connected to adistal end of the manifold in such a manner so as to define a channelbetween an outer surface of the distal end portion of the manifold andan inner surface of the cap.
 5. The apparatus according to claim 4,wherein the at least one ejection port includes at least one thirdejection port that communicates with the channel defined between theouter surface of the distal end portion of the manifold and the innersurface of the cap.
 6. The apparatus according to claim 5, furthercomprising: a third conduit having a distal end in fluid communicationwith the third ejection port.
 7. The apparatus according to claim 6,wherein the first conduit is connectable to a first fluid source, thesecond conduit is connectable to a second fluid source, and the thirdconduit is connectable to a third fluid source.
 8. The apparatusaccording to claim 7, wherein the first fluid source includes a firstpart of a multi-part wound treatment material, and wherein the secondfluid source includes a second part of the multi-part wound treatmentmaterial.
 9. The apparatus according to claim 8, wherein the multi-partwound treatment material is a sealant.
 10. The apparatus according toclaim 9, wherein the third source includes a fluid.
 11. The apparatusaccording to claim 10, wherein the cap and the distal end portion of themanifold are shaped so that the channel directs the fluid in asubstantially proximal direction.
 12. The apparatus according to claim11, wherein the fluid ejected from the channel causes the first andsecond parts of the multi-part wound treatment material to mix.
 13. Theapparatus according to claim 1, wherein the actuation assembly comprisesat least one handle connected to the body portion.
 14. The apparatusaccording to claim 13, wherein the approximation assembly includes: athreaded rod member threadingly engaging the at least one handle; and aknob member operatively connected to a proximal end of the threaded rodmember.
 15. The apparatus according to claim 14, wherein the dispersionassembly is operatively associated with the distal end of the threadedrod member.
 16. The apparatus according to claim 15, wherein thethreaded rod member includes windows formed on opposite sides thereof,wherein the windows are in registration with the at least one ejectionport.
 17. The apparatus according to claim 16, wherein the distal end ofthe threaded rod member comprises a connection member defining thewindows, wherein a distal end of the connection member is configured toselectively engage a stem of an anvil assembly.
 18. A circular surgicalstapling apparatus, comprising: a tubular body portion having anactuator; a staple pusher member operatively disposed at a distal end ofthe tubular body portion and being operatively connected to the actuatorfor expelling an annular array of staples from the tubular body portion;an anvil assembly movably mounted at the distal end of the tubular bodyportion for movement toward and away from the tubular body portion; anapproximation assembly extending between the tubular body portion andthe anvil assembly for moving the anvil assembly toward and away fromthe tubular body portion; a nozzle operatively associated with theapproximation assembly, the nozzle including at least one ejection portdisposed between the anvil assembly and the tubular body portion andbeing configured to dispense at least one fluid, wherein the nozzleincludes a manifold having: a plurality of first ejection ports formedtherein for dispensing a first wound treatment material; and a pluralityof second ejection ports formed therein for dispensing a second woundtreatment material different from the first wound treatment material;wherein the plurality of first ejection ports and the plurality ofsecond ejection ports are both provided on opposed sides of themanifold; wherein the plurality of first ejection Ports and theplurality of second ejection ports are radially oriented; and at leastone conduit for conducting wound treatment material to the nozzle. 19.The apparatus according to claim 18, wherein the at least one conduitincludes: a first conduit having a distal end in fluid communicationwith the plurality of first ejection ports formed in the manifold; and asecond conduit having a distal end in fluid communication with theplurality of second ejection ports formed in the manifold.
 20. Theapparatus according to claim 19, wherein a distal end portion of themanifold is tapered at an angle relative to a longitudinal axis, and theplurality of first ejection ports and the plurality of second ejectionports are disposed in the distal end portion of the manifold.
 21. Theapparatus according to claim 20, wherein the nozzle further includes: acap operatively connected to a distal end of the manifold in such amanner so as to define a channel between an outer surface of the distalend portion of the manifold and an inner surface of the cap.
 22. Theapparatus according to claim 21, wherein the at least one ejection portincludes at least one third ejection port that communicates with thechannel.
 23. The apparatus according to claim 22, further comprising: athird conduit having a distal end in fluid communication with the thirdejection port.
 24. The apparatus according to claim 23, wherein thefirst conduit is connectable to a first fluid source, the second conduitis connectable to a second fluid source, and the third conduit isconnectable to a third fluid source.
 25. The apparatus according toclaim 24, wherein the first fluid source includes a first part of atwo-part wound treatment material, and wherein the second sourceincludes a second part of the two-part wound treatment material.
 26. Theapparatus according to claim 25, wherein the two-part wound treatmentmaterial is a bio-adhesive.
 27. The apparatus according to claim 26,wherein the third fluid source includes a compressed fluid.
 28. Theapparatus according to claim 27, wherein the cap and the distal endportion of the manifold are shaped so that the channel directs the fluidinto a substantially proximal direction.
 29. The apparatus according toclaim 28, wherein the fluid ejected from the channel causes the firstand second parts of the two-part wound treatment material to mix. 30.The apparatus according to claim 18, wherein the actuator comprises atleast one handle connected to the tubular body portion.
 31. Theapparatus according to claim 30, wherein the approximation assemblyincludes: a threaded rod member threadingly engaging the at least onehandle; and a knob member operatively connected to a proximal end of thethreaded rod member.
 32. The apparatus according to claim 31, whereinthe nozzle of the wound treatment material dispersion system isoperatively associated with the distal end of the threaded rod member.33. The apparatus according to claim 32, wherein the threaded rod memberincludes windows formed on opposite sides thereof, the windows being inregistration with the at least one ejection port.
 34. The apparatusaccording to claim 33, wherein the distal end of the threaded rod membercomprises a connection member defining the windows, a distal end of theconnection member is configured to selectively engage a stem of an anvilassembly.